Has a change in established care pathways during the first wave of the COVID-19 pandemic led to an excess death rate in the fragility fracture population? A longitudinal cohort study of 1846 patients

Objective During the first wave of the COVID-19 pandemic, changes to established care pathways and discharge thresholds for patients with fragility fractures were made. This was to increase hospital bed capacity and minimise the inpatient risk of contracting COVID-19. This study aims to identify the excess death rate in this population during the first wave of the pandemic. Design A longitudinal cohort study of patients with fragility fractures identified by specific International Classification of Diseases (ICD)-10 codes. The first wave of the pandemic was defined as the 3-month period between 1 March and 1 June 2020. The control group presented between 1 March and 1 June 2019. Setting Two acute National Health Service hospitals within the East Midlands region of England. Participants 1846 patients with fragility fractures over the aforementioned two specified matched time points. Primary and secondary outcome measures Four-month mortality of all patients with fragility fractures with a subanalysis of patients with fragility hip fractures. Results 832 patients with fragility fracture were admitted during the pandemic period (104 diagnosed with COVID-19). 1014 patients presented with fragility fractures in the control group. Mortality in patients with fragility fracture without COVID-19 was significantly higher among pandemic period admissions (14.7%) than the pre-pandemic cohort (10.2%) (HR=1.86; 95% CI 1.41 to 2.45; p<0.001) adjusted for age and sex. Length of stay was shorter during the pandemic period (effect size=−4.2 days; 95% CI −5.8 to –3.1, p<0.001). Subanalysis of patients with fragility hip fracture revealed a mortality of 8.4% in the pre-pandemic cohort, and 15.48% during pandemic admissions with no COVID-19 diagnosis (HR=2.08; 95% CI 1.11 to 3.90; p=0.021). Conclusions There is a significant increase in excess death, not explained by confirmed COVID-19 infections. Altered care pathways and aggressive discharge criteria during the pandemic are likely responsible for the increase in excess deaths.

Covid testing was notoriously unreliable during the first peak of the pandemic, and it has been estimated that at least 30% of tests were false negative (BMJ 2021;372:n287) We therefore moved away from relying on PCR testing and started making a 'clinical diagnosis'. It has not been made clear at what stage of the admission the Covid negative status was confirmed or how often this had been repeated during the hospital stay. Had study subjects been tested for their Covid status post discharge?

REVIEWER
Ong, Terence University of Malaya REVIEW RETURNED 30-Nov-2021

GENERAL COMMENTS
It is a sobering read and is a further reminder (not that we need it) of how Covid19 has affected patients and the healthcare system that looks after them. Some clarification required from me -The choice of ICD-10 codes. All patients in the control group would not have had covid testing since this was in the pre pandemic period, we therefore assume that all patients in this cohort are Covid-19 negative.
For the patients in the study group (pandemic period) all patients received a covid test on admission please note in the material and methods section "COVID status (as identified in the medical records as "Coronavirus SARS-COV-2" positive patients or with a positive reverse transcriptase polymerase chain reaction; rPCR)" Covid testing was repeated every 3 days as according to guidelines. Post discharge covid testing was not performed as these patients either ended up home or institutionalised. Predischarge covid testing was performed as part of routine inpatient testing to identify potential carriers to permit the required isolation period before returning to potential household or care home contacts.
We have therefore included the following as an additional statement in the material and methods section. We hope this satisfies this comment

Reviewer 2 Comments
Thank you for your comments 1. It is a sobering read and is a further reminder (not that we need it) of how Covid19 has affected patients and the healthcare system that looks after them. Some clarification required from me -The choice of ICD-10 codes. Why only include S72 (femur fracture) and not the other codes pertaining to fractures affecting, eg pelvis, upper limbs, lower limbs?
Our choice of ICD-10 codes was used to identify those patients specifically with fragility fractures i.e., fall from standing height. An inclusion of all fractures would include patients who sustained high energy trauma, paediatric patients, patients with different mechanism of injury and these injuries can be managed differently in different units. This would increase the heterogeneity of the results. By using the ICD-10 codes we have, we are able to identify those patients who are elderly with significant medical co-morbidities the patient population in whom Covid-19 affected severely and in whom evidenced based hospital pathways have been formulated to try and improve clinical outcomes in an already atrisk population. Being specific with S72 femur Materials and methods fracture, we would be able to provide a more precise recommendation following our analysis of the results with regards to changing of patient care pathways. We have therefore elected not to change the ICD-10 codes as we feel these codes capture this group of patients well and still provides a useful message to disseminate to the wider audience of BMJ Open readers.
We hope this satisfies this comment. We appreciate that there are differences in outcomes depending on injury pattern and location. Unfortunately, we do not have the data to go into each individual injury. Many injuries although roughly managed similarly across the country are not subject to strict national guidelines and therefore would be difficult to compare amongst regions and countries. The hip fracture population are managed ubiquitously as the standards are set out by the National Institute of Clinical Excellence (NICE). We therefore provided this group as a subgroup analysis. This group of patients has a significant morbidity and mortality even prior to the effect of the pandemic on care pathways and any change in established care pathway we would presume would affect this group more sensitively.
We have added the following to the materials and methods section to highlight the above explanation. "These ICD-10 codes were selected to capture patients who were likely presenting with fragility fractures, and were identified from data entered We have therefore elected not to change this in our manuscript, however if the editor wishes we could amend this if it were deemed imperative to do so.
We hope the above satisfies this comment. 1. Outcomes were adjusted according to age and gender. If differences exist for types of fracture and frailty, it would be interesting to see if outcomes were any different.
We acknowledge this comment, unfortunately to capture each fracture subtype within the remit of fragility fractures would have been a too exhaustive task.
We hope the above satisfies this comment.
1. Analysis for difference in length of stay used Student's T-test. The Ttest assumes normal distribution of the continuous data. Length of stay tends to be (positively) skewed.
We acknowledge that length of stay tends to be positively skewed, and the Students T-test assumes normal distribution. Therefore, we have used the Kruskal-Walllis test (nonparametric test) and re run the analysis. We have made the amendments to table 2 and 3.
We hope the above satisfies this comment. Hip fractures were still managed according to best practice tariff and NICE guidelines, unfortunately data on time of injury to presentation was not collected and therefore we are unable to add this into the analysis for this study.
We hope the above satisfies this comment. 1.